Skip to content

Advertisement

  • Oral presentation
  • Open Access

Using existing trial data to inform the development of core outcome sets and improve efficiencies in research

  • 1,
  • 2,
  • 2,
  • 3,
  • 4 and
  • 5
Trials201516(Suppl 2):O74

https://doi.org/10.1186/1745-6215-16-S2-O74

Published: 16 November 2015

Keywords

  • Trial Data
  • Measurement Instrument
  • Optimum Frequency
  • Core Outcome
  • Structural Validity

Introduction

One way of improving efficiency of research is to use core outcome sets, which allow results from different trials to be compared. Obtaining consensus over core outcome sets requires evidence on the validity, reliability and responsiveness of chosen measurement instruments. Re-using existing trial datasets to conduct validation studies of measurement instruments could be an efficient and timely means of filling known validation gaps.

Methods

Using an exemplar from the field of eczema, evidence presented at meetings of the Harmonizing Outcome Measures for Eczema (HOME) initiative (http://www.homeforeczema.org) was reviewed, and included: qualitative surveys (content validity); systematic reviews of existing trials (to identify preferred outcome instruments); and systematic reviews of validation studies (to identify validation gaps). Known validation gaps were identified and mapped to five existing trial datasets, to establish which gaps could feasibly be filled using existing primary data (NIHR-funded eczema trials: (SWET - HTA:05/16/01, CLOTHES - HTA:11/65/01, CREAM - HTA:09/118/03, BATHE - HTA:11/153/01, COMET - RfPB: PB-PG-0712-28056).

Results

The five included trials contain data on outcome instruments relating to all four core outcome domains for eczema. Results will be presented to show how existing trial datasets have been used to address validation gaps including construct validity (structural validity and hypothesis testing), reliability (internal consistency) and responsiveness to change. Trial data have also been used to help define the construct of long-term control; particularly the definition of eczema flares and optimum frequency of data collection.

Conclusions

Re-using existing trial datasets to inform core outcome set development is feasible, efficient and timely.

Authors’ Affiliations

(1)
Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK
(2)
Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK
(3)
Cochrane Institute of Primary Care and Public Health, Cardiff, UK
(4)
Centre for Academic Primary Care, School of Social and Community Medicine, Bristol, UK
(5)
Department of Primary Care and Population Sciences, University of Southampton, Southampton, UK

Copyright

© Thomas et al. 2015

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Comments

By submitting a comment you agree to abide by our Terms and Community Guidelines. If you find something abusive or that does not comply with our terms or guidelines please flag it as inappropriate. Please note that comments may be removed without notice if they are flagged by another user or do not comply with our community guidelines.

Advertisement